Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT06164002
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-06
First Post:
2023-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A I in the Prediction of Clinical Performance, Marginal Fit and Fracture Resistance of Vertical Versus Horizontal Margin Designs Fabricated With 2 Ceramic Materials
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001185', 'term': 'Artificial Intelligence'}, {'id': 'D008954', 'term': 'Models, Biological'}], 'ancestors': [{'id': 'D000465', 'term': 'Algorithms'}, {'id': 'D055641', 'term': 'Mathematical Concepts'}, {'id': 'D008962', 'term': 'Models, Theoretical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2023-08-16', 'studyFirstSubmitQcDate': '2023-12-01', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Artificial intelligence application assessment, laboratory marginal fit and fracture resistance', 'timeFrame': '6 months', 'description': 'Predicting the follow up results using the new (artificial intelligence "AI") model for vertical "feather-edge" versus horizontal "shoulder" margin designs fabricated with two ceramic materials (zirconia and hybrid ceramic) that saves the clinical evaluation period, hence saves the expenses of the dental clinic.'}], 'secondaryOutcomes': [{'measure': 'In-Vitro Study preparations.', 'timeFrame': '6 months', 'description': 'Marginal Adaptation "feather-edge" versus horizontal "shoulder" margin designs fabricated with two ceramic materials (zirconia and hybrid ceramic).'}, {'measure': 'In-Vitro Study', 'timeFrame': '6 months', 'description': 'Fracture Resistance'}, {'measure': 'In-Vivo Study', 'timeFrame': 'Baseline,3 months,6 months', 'description': 'Clinical Examination'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Artificial Intelligence']}, 'descriptionModule': {'briefSummary': 'The present study will be performed to evaluate application of artificial intelligence in the prediction of clinical performance, marginal fit and fracture resistance of vertical "feather-edge" versus horizontal "shoulder" margin designs fabricated with two ceramic materials (zirconia and hybrid ceramic)', 'detailedDescription': 'The objective of the present study is to characterize two different margin designs (vertical "feather-edge" and horizontal "shoulder") with two different ceramic materials (zirconia and hybrid ceramic) in terms of clinical performance, marginal fit and fracture resistance.\n\nPrimary outcome:\n\nPredicting the follow up results using the new (artificial intelligence "AI") model for vertical "feather-edge" versus horizontal "shoulder" margin designs fabricated with two ceramic materials (zirconia and hybrid ceramic) that saves the clinical evaluation period, hence saves the expenses of the dental clinic.\n\nSecondary outcome:\n\nEvaluating the clinical performance, marginal fit and fracture resistance of vertical "feather-edge" versus horizontal "shoulder" margin designs fabricated with two ceramic materials (zirconia and hybrid ceramic).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Age range of patients should be 20-50 years old, able to read and sign the informed consent document. 2. Patient with posterior molars indicated for full coverage restorations. 3. Patient should be able to physically and psychologically tolerate conventional restorative procedures. 4. Patients who are willing to return for follow-up examination and evaluation. 5. Indicated molar should have adequate tooth preparation length to ensure proper retention and resistance form. 6. Patient with sound contralateral or adjacent tooth to the selected tooth requiring full coverage restoration.\n\nExclusion Criteria:\n\n1. Patient in the growth stage with partially erupted teeth.\n2. Patient with poor oral hygiene and motivation.\n3. Pregnant women.\n4. Patient with psychiatric problems or unrealistic expectations.\n5. Patients with no opposing occluding dentition in the area intended for restoration.\n6. Patients with parafunctional habits. -'}, 'identificationModule': {'nctId': 'NCT06164002', 'briefTitle': 'A I in the Prediction of Clinical Performance, Marginal Fit and Fracture Resistance of Vertical Versus Horizontal Margin Designs Fabricated With 2 Ceramic Materials', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Faculty of Dental Medicine for Girls'}, 'officialTitle': 'Application of Artificial Intelligence in the Prediction of Clinical Performance, Marginal Fit and Fracture Resistance of Vertical Versus Horizontal Margin Designs Fabricated With Two Ceramic Materials', 'orgStudyIdInfo': {'id': 'P-CR-23-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group (I)', 'description': 'Patients will be prepared with vertical "feather edge" margin design.', 'interventionNames': ['Other: change in restoration material and margin design.']}, {'type': 'EXPERIMENTAL', 'label': 'Group (II)', 'description': 'Patients will be prepared with horizontal "shoulder" margin design.', 'interventionNames': ['Other: change in restoration material and margin design.']}, {'type': 'EXPERIMENTAL', 'label': 'Subgroup (A)', 'description': 'Patients will receive zirconia ceramic crowns', 'interventionNames': ['Other: change in restoration material and margin design.']}, {'type': 'EXPERIMENTAL', 'label': 'Subgroup (B)', 'description': 'Patients will receive hybrid ceramic crowns.', 'interventionNames': ['Other: change in restoration material and margin design.']}], 'interventions': [{'name': 'change in restoration material and margin design.', 'type': 'OTHER', 'otherNames': ['Predicting the follow up results using the new (artificial intelligence "AI") model'], 'description': 'comparing two different materials and two different designs. use artificial intelligence in the prediction of follow up results', 'armGroupLabels': ['Group (I)', 'Group (II)', 'Subgroup (A)', 'Subgroup (B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02', 'city': 'Cairo', 'state': 'Al-Azhar University', 'country': 'Egypt', 'facility': 'Walaa Tarek El Hefnawy', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculty of Dental Medicine for Girls', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assisstant lecturer', 'investigatorFullName': 'Walaa Tarek Mohamed', 'investigatorAffiliation': 'Faculty of Dental Medicine for Girls'}}}}